# K170211: Insight Dental System

- Pathway: 510(k) (Traditional)
- Applicant: Insight Dental System
- Decided: Apr 27, 2017 after 93 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K960026 (1996). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143022: BioHorizons Tapered Internal Implants, BioHorizons Implant Systems, Inc. (2015) Summary page 4.

## Indications for use
The Insight Dental Implant System is intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The Insight Dental Implant System is intended for delayed loading.

Source page: https://510kreport.com/device/K170211
Methodology: https://510kreport.com/methodology